'Female viagra' leaps closer to US approval

US Food and Drug Administration advisors are backing approval of Sprout’s ADDYI as the world’s first medicine for low female libido, on the proviso that the firm develops a risk management programme to keep its safety in check.

There was a big question mark over which way the voting would go after documents posted to the agency’s website earlier this week highlighted potentially serious safety issues with the pill, including fainting and low blood pressure when taken alongside alcohol and other medicines.

But advisors from the FDA’s Bone, Reproductive and Urologic Drugs Advisory and Drug Safety and Risk Management Advisory Committees ended up voting 18-6 in favour of ADDYI (flibanserin) for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women, pushing the drug a giant step closer to the US market, but only if certain risk management options beyond labelling are implemented.

HSDD is the most commonly reported form of female sexual dysfunction, characterised by a deficiency or absence of sexual fantasies and desire for sexual activity, which causes marked distress or interpersonal difficulty. Around one in three women in the US suffer from low sexual desire, and one in 10 are distressed by it, Sprout notes.

In clinical trials, 43%-60%women who had been in long-term relationships for 10 years, with HSDD for half of that time on average, experiences an improvement within six months of treatment with ADDYI.

A final decision by the FDA, which has twice rejected the drug, is expected in August.